Explore ITB Therapy

ITB Therapy^SM (Intrathecal Baclofen Therapy) delivers a liquid form of baclofen, Lioresal^® Intrathecal (baclofen injection), directly into the intrathecal space where fluid flows around the spinal cord. ITB Therapy may relieve severe spasticity with small amounts of Lioresal Intrathecal delivered via a programmable pump that is surgically placed and connected to a catheter in the body. Because the drug is delivered directly to where it is needed in the spinal fluid, it does not circulate throughout the body in the blood. This may help minimize potential side effects that often accompany oral baclofen.

ITB Therapy has been shown in studies to significantly reduce spasticity.^1-3 There have been reports that ITB Therapy helped people be more independent, allowing them to feed or dress themselves, sit more comfortably, or transfer more easily.^3-8 Caregivers also reported satisfaction with ITB Therapy.^{8, 9}

Learn whether this therapy may be right for you or someone in your care by exploring the links below.

IMPORTANT SAFETY INFORMATION ON ITB THERAPY:

Please follow your doctor's instruction closely because a sudden stop of intrathecal baclofen therapy can result in serious illness (baclofen withdrawal symptoms) such as high fever, changed mental status, muscle rigidity, and in rare cases multiple organ-system failure and death. It is very important that your doctor be called right away if you experience any of the above symptoms.

It is important for you to keep your scheduled refill visits so you don't run out of medication (baclofen) and to understand the early symptoms of baclofen withdrawal. Some patients are at more risk than others for baclofen withdrawal; consult with your doctor.

People who suffer from severe spasticity resulting from cerebral palsy, multiple sclerosis, stroke, traumatic brain injury, or spinal cord injury may be a candidate for ITB Therapy. If you have spasticity due to spinal cord injury or multiple sclerosis you must first fail oral baclofen. If you have experienced a traumatic brain injury you must first wait one year after the injury to be considered for ITB Therapy. A screening test will help show if you will respond to the intrathecal baclofen. You should not receive ITB Therapy if you have an infection, are allergic to baclofen, or your body size is too small to hold the implantable pump.

The implanted pump and catheter are surgically placed beneath the skin. Surgical complications that you may experience include infection, meningitis, spinal fluid leak, paralysis, headache, swelling, bleeding, and bruising.

The most common and/or serious drug-related side effects of ITB Therapy include loose muscles, sleepiness, upset stomach, vomiting, headaches, and dizziness. Pump failure may cause overdose or underdose of intrathecal baclofen. The signs and symptoms of overdose include drowsiness, lightheadedness, respiratory depression (difficulty breathing), seizures, loss of consciousness, and coma. Once the infusion system is implanted, device complications include catheter or pump moving within the body or eroding through the skin. The catheter could leak, tear, kink, or become disconnected, resulting in underdose or no baclofen infusion. Symptoms of underdose include increase or return in spasticity, itching, low blood pressure, lightheadedness, and tingling sensation. These symptoms are often early indications of baclofen withdrawal. The pump could stop because the battery has run out or because of component failure. The pump will sound an alarm when the pump needs to be filled with baclofen, replaced or if there is a problem with the pump. Always inform any healthcare personnel that you have an implanted infusion system before any medical or diagnostic procedure such as MRI, diathermy, etc.

For more information, please read the Lioresal^® Intrathecal (baclofen injection) Full Prescribing Information and the SynchroMed Infusion System Information.

Lioresal^® is a registered trademark of Novartis Pharmaceuticals Corporation.